NCT01758835

Brief Summary

PRCT multicenter study to evaluate non-operative treatment protocols for treating ER-stress negative unimalleolar Weber-B type fibular fractures. Groups are: 1. 3 weeks in a removable splint 2. 3 weeks in a cast and 3. 6 weeks in a cast. Follow-up visits at 3, 6 and 12 weeks and after 1 and 2 years after injury. In each time X-rays laterally and mortise projections. Ankle functional outcome questionnaires: Olerud-Molander score, FAOS RAND-36 and VAS in follow up-visits 6 and 12 weeks and 1 and 2 year.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
247

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 1, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 18, 2018

Status Verified

October 1, 2018

Enrollment Period

3.7 years

First QC Date

December 21, 2012

Last Update Submit

October 16, 2018

Conditions

Lateral Malleolus Fractures

Keywords

ER-stress-test negativeunimalleolarfibulaWeber-B fractures

Outcome Measures

Primary Outcomes (1)

  • Olerud-Molander score

    Ankle functional outcome measure

    1 year

Secondary Outcomes (4)

  • FAOS

    1 year

  • VAS

    1 year

  • RAND 36 Health item survey

    1 year

  • Fracture healing

    1 year

Study Arms (3)

Splint 3 weeks

ACTIVE COMPARATOR

Removable ankle brace/splint

Other: Splint 3 weeks

Cast 3 weeks

ACTIVE COMPARATOR

Below-the-knee cast (glass fiber)

Other: Cast 3 weeks

Cast 6 weeks

ACTIVE COMPARATOR

Below-the-knee cast (glass fiber)

Other: Cast 6 weeks

Interventions

Splint 3 weeksOTHER

A removable orthosis/splint. Dynacast/Ortho-Glass AS (BSN Medical). Splint is used for 3 weeks and no additional support is used after splint removal.

Splint 3 weeks
Cast 3 weeksOTHER

A standard short boot cast from proximal tibia to MTP I-V joint line. Cast is made from 3M Scotchcast. Cast is removed after 3 weeks and no additional support is used after cast removal.

Cast 3 weeks
Cast 6 weeksOTHER

standard short boot cast from proximal tibia to MTP I-V joint line. Cast is made from 3M Scotchcast. Cast is changed after 3 weeks and removed after 6 weeks. No additional support is used after cast removal.

Cast 6 weeks

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Stable Weber-B type fibula fracture
  • ER-stress negative
  • or over years old
  • Willingness to participate on study proved by a signature and date
  • Walking without aid before accident
  • Treatment started within 7 days from injury

You may not qualify if:

  • Prior ankle fracture or significant fracture in the area of ankle or leg
  • Bilateral ankle fracture
  • Pathological fracture
  • Diabetes mellitus or an other significant periferial neuropathy
  • municipality of Residence in some else catchment area than Oulu university hospital or Tampere university hospital
  • Patient's understanding or co-operation inadequate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OYS, kirurgian klinkka, Oulu

Oulu, 90100, Finland

Location

Related Publications (1)

  • Kortekangas T, Haapasalo H, Flinkkila T, Ohtonen P, Nortunen S, Laine HJ, Jarvinen TL, Pakarinen H. Three week versus six week immobilisation for stable Weber B type ankle fractures: randomised, multicentre, non-inferiority clinical trial. BMJ. 2019 Jan 23;364:k5432. doi: 10.1136/bmj.k5432.

    PMID: 30674451DERIVED

MeSH Terms

Conditions

Ankle Fractures

Interventions

SplintsPOLR1G protein, human

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

External FixatorsOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentEquipment and SuppliesSurgical Fixation Devices

Study Officials

  • Harri J Pakarinen, MD, PhD

    Oulu University Hospital

    STUDY DIRECTOR

  • Tero HJ Kortekangas, MD

    Oulu University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic surgeon, MD, PhD

Study Record Dates

First Submitted

December 21, 2012

First Posted

January 1, 2013

Study Start

October 1, 2012

Primary Completion

June 1, 2016

Study Completion

December 1, 2017

Last Updated

October 18, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)